• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name oximeter
510(k) Number K082546
Device Name REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
Original Applicant
UNIMED MEDICAL SUPPLIES INC.
w322s8863 mccarthy dr.
mukwonago,  WI  53149
Original Contact don melnikoff
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/03/2008
Decision Date 12/02/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-